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Efficacy of Radial Shockwave Therapy for Treatment of Pain in Knee Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02197962
Recruitment Status : Completed
First Posted : July 23, 2014
Last Update Posted : October 5, 2016
Sponsor:
Collaborator:
University of Sao Paulo
Information provided by (Responsible Party):
Marta Imamura, University of Sao Paulo

Tracking Information
First Submitted Date  ICMJE July 17, 2014
First Posted Date  ICMJE July 23, 2014
Last Update Posted Date October 5, 2016
Study Start Date  ICMJE May 2010
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 4, 2016)
Visual Analog Scale [ Time Frame: Before intervention and after 3 months of the end of intervention ]
The Visual Analog Scale consists of a straight line of 10cm length which presents the phrase "absence of pain" (0) at one extremity, and unbearable pain (10) at the other extremity.
Original Primary Outcome Measures  ICMJE
 (submitted: July 21, 2014)
Visual Analog Scale [ Time Frame: Before intervension and after 3 months of the end of intervension ]
The Visual Analog Scale consists of a straight line of 10cm length which presents the phrase "absence of pain" (0) at one extremity, and unbearable pain (10) at the other extremity.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 4, 2016)
Level of tolerance of pain [ Time Frame: Immediately before the intervention, immediately after the intervention and 3 months after the intervention. ]
Measures will be taken with the Fisher algometry in the following muscles: vastus medialis, vastus lateralis, rectus femoris, gracilis, adductor longus, tibialis anterior, fibularis longus, quadratus lumborum, iliopsoas and popliteus; also at the pes anserinus and patellar tendon, the knee joint interface, the supraspinal of L1 to S1 and on the dermatomal from T12 to S2.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2014)
Level of tolerance of pain [ Time Frame: Immediately before the intervension, immediately after the intervension and 3 months after the intervension. ]
Measures will be taken with the Fisher algometry in the following muscles: vastus medialis, vastus lateralis, rectus femoris, gracilis, adductor longus, tibialis anterior, fibularis longus, quadratus lumborum, iliopsoas and popliteus; also at the pes anserinus and patellar tendon, the knee joint interface, the supraspinal of L1 to S1 and on the dermatomal from T12 to S2.
Current Other Pre-specified Outcome Measures
 (submitted: October 4, 2016)
The influence of pain over the functional capacity of patients based on the WOMAC questionnaire [ Time Frame: Immediately before the intervention and 3 months after the intervention. ]
Original Other Pre-specified Outcome Measures
 (submitted: July 21, 2014)
The influence of pain over the functional capacity of patients based on the WOMAC questionnaire [ Time Frame: Immediately before the intervension and 3 months after the intervension. ]
 
Descriptive Information
Brief Title  ICMJE Efficacy of Radial Shockwave Therapy for Treatment of Pain in Knee Osteoarthritis
Official Title  ICMJE Efficacy of Radial Shockwave Therapy for Treatment of Pain in Knee Osteoarthritis
Brief Summary The objective of this study is to compare the results of 2000 impulses of radius shockwaves per week with 2000 placebo shockwaves on the treatment of pain and functional incapacity of patients with severe primary knee osteoarthritis, who did not satisfactory respond to previous conventional treatments.
Detailed Description
  • Prospective, placebo controlled randomized and double-blind study.
  • Treatment Method:

Radial extracorporeal shockwaves will be applied using the Swiss Dolorclast (EMS Electro Medical Systems, Switzerland), generated by pneumatic waves.

Intervention:

  • Group 1 - Intervention group Patients will receive 2,000 impulses of radial shockwave per week, with pressure of 2.5bar to 4.0bar, at the frequency of 8Hz. The impulses will be applied at the most painful site of the knee joint interface on manual palpation, for three consecutive weeks.
  • Group 2 - Control Group:

Patients will receive 2,000 impulses of placebo radial shockwave per week, without any energy flow intensity. Frequency of 8Hz will appear in the screen. The impulses will be applied at the most painful site of the knee joint interface on manual palpation, for three consecutive weeks.

Post application program for both groups: Three consecutive days of:

  1. Hot packs (superficial heat) applied on the application site for 20 minutes;
  2. Simple analgesics, when needed (Acetaminophen 500mg every 6 hours, or analogue in case of allergy).

Outcome Evaluation:

The evaluation of pain intensity will be done according to the VAS (Visual Analog Scale) The influence of pain on the functional capacity of patients will be measured with WOMAC (Western Ontario and McMaster Osteoarthritis Index) for knee evaluation.

Another evaluation criteria will be the level of tolerance of pressure on several muscles and other parts as the pes anserinus and patellar tendon, the knee joint interface, and the supraspinal of L1 to S1 also on the dermatomal from T12 to S2. These measures will be done by the Fisher algometry.

The evaluations will be carried out before the treatment, immediately after the treatment and 3 months after the end of the treatment.

Analgesia drut will be prescribed, if patients feel pain during the days after the application.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Knee Osteoarthritis
Intervention  ICMJE
  • Device: Extracorporeal Radial shockwaves
    Patients will receive 2,000 impulses of extracorporeal radial shockwaves or per week, with pressure of 2.5bar to 4.0bar, at the frequency of 8Hz. The impulses will be applied at the most painful site of the knee joint interface on manual palpation, for three consecutive weeks.
  • Device: Placebo Radial Shockwaves
    Patients will receive 2,000 impulses of placebo extracorporeal radial shockwaves per week, without any pressure, therefore no energy will be applied, at the frequency of 8Hz. The impulses will be applied at the most painful site of the knee joint interface on manual palpation, for three consecutive weeks.
Study Arms  ICMJE
  • Experimental: Extracorporeal radial shockwaves
    Patients will receive 2,000 impulses of extracorporeal radial shockwave per week, with pressure of 2.5bar to 4.0bar, at the frequency of 8Hz. The impulses will be applied at the most painful site of the knee joint interface on manual palpation, for three consecutive weeks.
    Intervention: Device: Extracorporeal Radial shockwaves
  • Placebo Comparator: Placebo Radial Shockwaves
    Patients will receive 2,000 impulses of placebo radial shockwave per week, without any energy flow intensity. Frequency of 8Hz will appear in the screen. The impulses will be applied at the most painful site of the knee joint interface on manual palpation, for three consecutive weeks.
    Intervention: Device: Placebo Radial Shockwaves
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 4, 2016)
105
Original Estimated Enrollment  ICMJE
 (submitted: July 21, 2014)
10
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Clinical and radiological diagnosis of primary knee diagnosis.
  • Pain intensity: Visual Analog Scale (VAS) ≥ 6;
  • One of more failures with conventional treatment (drugs, Non-Steroidal Anti-inflammatory Drugs - NSAD, physiotherapy, stretching, acupuncture, orthosis and others);
  • Age over 60 years;
  • No use of corticosteroids in the prior 48 hours;
  • No major osteoarthritis events in other joints of lower limbs (waist and ankle) and lower back;
  • No clinical evidence of related neuropathy, including radiculopathy and peripheral neuropathy;
  • Absence of systemic inflammatory disease (Rheumatoid arthritis, Reiter, ankylosing spondylitis, generalized polyarthritis, cancer);
  • Absence of infection or cancer at the application site;
  • Absence of related endocrine and metabolic diseases;
  • Absence of fibromyalgia, diagnosed after the American College of Rheumatology, 1999;
  • Absence of severe blood dyscrasias;
  • Absence of severe psychiatric disturbances that requires psychiatric assessment;
  • Availability to comply with the clinic visits and follow up evaluations along the treatment

Exclusion Criteria:

  • Patients who withdraw the informed consent form at any time
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02197962
Other Study ID Numbers  ICMJE Radial Shockwave
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Marta Imamura, University of Sao Paulo
Study Sponsor  ICMJE Marta Imamura
Collaborators  ICMJE University of Sao Paulo
Investigators  ICMJE
Principal Investigator: Marta Imamura, MD Instituto de Medicina Fisica e Reabilitacao HCFMUSP
PRS Account University of Sao Paulo
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP